The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThomas Jefferson University

About this trial

The goal of this clinical trial is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) intervention targeting Abdominal Core Health components in patients recovering from ventral hernia repair. The study focuses on patients aged 18-75 diagnosed with a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective Ventral Hernia Repair (VHR).

The main questions it aims to answer are:

* Will tailored PT significantly improve abdominal core strength, biomechanical stability, and functional mobility compared to usual care at 3-months post-surgery? * Will tailored PT lead to higher patient-reported quality of life and satisfaction scores, with a lower incidence of post-operative complications such as bowel obstruction and pelvic floor dysfunction over a 1-year follow-up? * Will tailored PT result in decreased healthcare utilization, leading to overall cost savings or neutrality compared to usual care over the first year after VHR?

Researchers will compare the tailored physical therapy group to a usual care group to see if the tailored intervention leads to significant improvements in clinical efficacy, patient outcomes, and cost-effectiveness.

Participants will:

* Be randomly assigned to either the Usual Care Group or the PT Group. * If in the Usual Care Group, receive standard post-operative instructions for 12 weeks, including guidance on binder use, safe lifting, and gradual return to activities. * If in the PT Group, receive foundational post-operative instructions for the first 2 weeks (similar to usual care). Undergo 6 structured and individualized PT sessions over 10 weeks if in the PT Group, with progression based on Oswestry Disability Index (ODI) and Pelvic Floor Distress Inventory-20 (PFDI-20) scores, including Symptom Modulation, Movement Control, Functional Optimization, or Impairment-Based interventions.

Participants undergo data collection at 2 weeks, 12 weeks, and 1 year post-operation, including imaging, functional mobility tests, pain scales, patient-reported outcomes, physical measurements, and tracking of complications and healthcare utilization. Participate in semi-structured interviews after the 12-week assessment to provide qualitative insights into their experiences and perceived barriers/facilitators.

Eligibility criteria

Qualifiers

Participants must be aged 18-75.

Diagnosed clinically or via objective testing by a surgeon with a ventral transverse hernia >4 cm and <10 cm.

Scheduled for elective surgical correction of a non-recurrent, primary or incisional ventral hernia.

Independent functional status.

Disqualifiers

Individuals currently receiving or who have received PT within the last 30 days.

Individuals currently using an assistive device for ambulation.

Individuals diagnosed with a neurologic disorder will be excluded.

History of or plan for Botox injection or muscle release related to the hernia.

Trial design

Treatments tested in this trial

  • PT Group
  • Usual Care

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators